Preventing Aggression in Veterans With Dementia (PAVeD)
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| First Received Date ICMJE | March 28, 2011 | ||||||||
| Last Updated Date | May 21, 2013 | ||||||||
| Start Date ICMJE | May 2011 | ||||||||
| Estimated Primary Completion Date | February 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Cohen-Mansfield Agitation Inventory (aggression subscale) [ Time Frame: Three Months, Six Months, Twelve Months Post Intervention ] [ Designated as safety issue: No ] Incidence of aggression |
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| Original Primary Outcome Measures ICMJE |
Cohen-Mansfield Agitation Inventory (aggression subscale) [ Time Frame: Three Months, Six Months, Twelve Months Post Intervention ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT01325714 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Preventing Aggression in Veterans With Dementia | ||||||||
| Official Title ICMJE | Preventing Aggression in Veterans With Dementia | ||||||||
| Brief Summary | This study tests whether education about memory and pain might help to prevent aggression in persons with dementia who have pain. The overall goal of this intervention is to reduce the risk of aggressive behavior by improving several areas of patient life that are known causes of aggression: pain, depression, lack of pleasurable activities, caregiver stress and difficulty in caregiver-patient communication. |
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| Detailed Description | Dementia is known primarily for its effects on memory, however, eighty percent of persons with dementia also have behavioral disturbances. This is often not addressed, leading to increased use of nursing homes, higher incidence of injury (both patient and caregiver) and the use of tranquilizing medications. Pain is one of the strongest predictors of aggression. The prevalence of pain in persons with dementia is known to be about 50%. Untreated pain is associated with significant negative outcomes, including increased health care use, inactivity and isolation. We aim to determine whether outcome differences exist between active intervention and control conditions in relation to the occurrence of aggressive behavior, pain and depression, and its impact on pleasant activities, caregiver burden, quality of caregiver-patient relationship, antipsychotic use, health-service use, injuries to patient and caregiver, and nursing home placement. The active intervention, Preventing Aggression in Veterans with Dementia (PAVeD), is a family caregiver-focused, home-based intervention that uses psychoeducational and behavioral approaches to help reduce the risk of aggressive behavior in persons with dementia. The objective of PAVeD is to improve several areas of patient life that are known causes of aggression: pain and distress (including mood problems), lack of pleasurable activities, and difficulty in patient-caregiver communication that may negatively affect relationship quality and caregivers' recognition of pain. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
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| Intervention ICMJE |
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| Publications * | Bradford A, Shrestha S, Snow AL, Stanley MA, Wilson N, Hersch G, Kunik ME. Managing pain to prevent aggression in people with dementia: a nonpharmacologic intervention. Am J Alzheimers Dis Other Demen. 2012 Feb;27(1):41-7. doi: 10.1177/1533317512439795. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 220 | ||||||||
| Estimated Completion Date | March 2015 | ||||||||
| Estimated Primary Completion Date | February 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Patients will be eligible to participate in the study if they meet the following criteria:
Exclusion Criteria: Patients will be excluded if they have had history of aggression in the past year
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| Gender | Both | ||||||||
| Ages | 60 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01325714 | ||||||||
| Other Study ID Numbers ICMJE | IIR 09-351 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Department of Veterans Affairs | ||||||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||||||
| Verification Date | May 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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